Medical devices in India now require CDSCO License.
If you are a manufacturer of either Class A or Class B medical devices as per the medical device classification list provided by CDSCO, you are now required to obtain a license from CDSCO to sell your device in the Indian market from 1st October 2022 onwards. failing to obtain the license will mean that you can no longer sell the device in the Indian market.
This comes after a notification was released by CDSCO under the public notices section of their website confirming that both Class A and B medical devices are under mandatory licensing regime w.e.f from 1st October 2022 while Class C and D devices that are considered to be higher risk will be under mandatory licensing scheme from 1st October 2023. the move comes after a transition period of 2 years where Indian manufacturers and importers of medical devices had to do registration under which complying with the major part of the Medical device rules 2017 was not required.
How to obtain a CDSCO license?
In short, to obtain a CDSCO license for your class A or B medical device you have to comply with the Indian Medical device rules 2017 regulations that are a part of CDSCO’s Drugs and cosmetics act, 1940, these regulations sort of replicate the regulation model of Europe’s MDR. licensing requires the manufacturers and importers to show compliance with the fourth and fifth schedules of the MDR 17 regulations.
For a detailed explanation of how the process works check out our article on “Steps to obtain CDSCO license for Class A and B devices”.
Don’t know where to start? we have all the solutions for you regarding the CDSCO license. Contact us to discuss the project.
